Tornier, Inc: Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max T

Hazard

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

Details from the source

Reason for recall: Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI. Quantity: 233 Lot/code info: 1. UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352 2. UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352 3. UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351

UPC codes

00840338603623, 00840338603630, 00840338604033

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.